Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

NCT01492972 | Recruiting Phase 3 DMC

• 1 other identifier: GU003-10
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Conditions

Prostate Cancer

Keywords

Prostate; proton; radiation; intermediate risk

Outcome Measures

Primary Outcomes (1)

• Morbidity Outcomes

  To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression. Freedom from failure (FFF): The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression

  after the initial 100 patients have had a median follow up of at least three years and then every year.

Secondary Outcomes (13)

• Frequency and severity of grade 2 or higher GU and GI toxicity

  At 6 months

• Frequency and severity of GI and GU toxicity

  At 3 years

• Incidence of quality of life issues

  At completion of radiation therapy

• Incidence of Freedom from biochemical failure (FFBF)

  At 5 years

• Incidence of clinical failure: local and/or distant

  At 5 years

Study Arms (2)

Radiation Alone

ACTIVE COMPARATOR

Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy

Radiation: Radiation

Radiation + Androgen Suppression

EXPERIMENTAL

Androgen Suppression Therapy x 6 months + Radiation

Radiation: Radiation; Drug: Androgen Suppression Therapy

Interventions

Radiation RADIATION

Consists of: 1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE)) 2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy) 3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)

Radiation + Androgen Suppression; Radiation Alone

Androgen Suppression Therapy DRUG

Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)

Also known as: leuprolide, goserelin, buserelin, or triptorelin

Radiation + Androgen Suppression

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA \> = 10 and \< = 20, T stage T2b - T2c
• Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
• Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. \> 6 cores are strongly recommended.
• PSA values \< = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
• ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
• Patients must sign IRB approved study specific informed consent.
• Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
• Patients must be able to start treatment within 56 days of randomization.
• Patients must be at least 18 years old.
• For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
• For brachytherapy, prostate volume must be less than 55cc prior to AS.

You may not qualify if:

• Pelvic lymph nodes \> 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
• Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
• Previous pelvic radiation for prostate cancer.
• Previous androgen suppression therapy for prostate cancer.
• Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
• Prior systemic chemotherapy for prostate cancer.
• History of proximal urethral stricture requiring dilatation.
• Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
• Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).
• Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
• History of myocardial infarction within the last 6 months.

Sponsors & Collaborators

• Proton Collaborative Group: lead

Study Sites (4)

Mayo Clinic

Scottsdale, Arizona, 85259-5499, United States

RECRUITING

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, 60555, United States

RECRUITING

Oklahoma Proton Center

Oklahoma City, Oklahoma, 73142, United States

RECRUITING

Hampton University Proton Therapy Institute

Hampton, Virginia, 23666, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation; Leuprolide; Goserelin; Buserelin; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Carlos Vargas, MD

  Proton Collaborative Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 15, 2011
• Study Start: January 1, 2012
• Primary Completion (Estimated): December 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

US (4)